Operator's Manual
Table Of Contents
- 1. Introduction
- 1.1. Introduction
- 1.2. Safety Information
- 1.3. Device Description
- 1.4. Intended Purpose
- 1.5. BIS™ Advance Monitor System Indications and Contraindications
- 1.6. Patient Target Groups
- 1.7. Intended Users
- 1.8. Essential Performance
- 1.9. Adverse Events (Residual Risks)
- 1.10. The BIS™ Advance Parameters
- 1.11. Symbols
- 2. The BIS™ Advance Monitor — Equipment and Supplies
- 2.1. The BIS™ Advance System
- 2.2. Parts of the System
- 3. Installation and Preparation for Use
- 3.1. Operating Environment
- 3.2. Power Requirements and Battery Use
- 3.3. Battery Operation
- 3.4. Mounting the Docking Station
- 3.5. Preparing the Docking Station
- 3.6. Preparing the Monitor
- 3.7. Home Screen
- 3.8. Four-Channel Monitoring
- 3.9. Home Screen Trend Graphs
- 3.10. Home Screen Numeric Section
- 3.11. Home Screen Menus
- 3.12. Home Screen Options
- 3.13. Secondary Trend Selection
- 3.14. Home Screen Audio Alarm Settings
- 3.15. Settings and Maintenance
- 3.16. Info Options
- 3.17. Quick Reference Checklist
- 4. Operating the BIS™ Advance Monitoring System
- 4.1. Preparing for Operation
- 4.2. Cases
- 4.3. Alarms and Messages
- 4.4. Chart Data
- 4.5. Menu Map
- 4.6. Institutional Settings
- 5. Data Storage, Transfer, and Export
- 5.1. Cybersecurity and Data Integrity
- 5.2. Monitor Data Memory
- 5.3. BISx Data Memory
- 5.4. Types of Exported Data
- 5.5. Live Case Export
- 5.6. Saved Cases Export
- 5.7. Recording a Snapshot Event
- 5.8. BIS™ Saved Data Files
- 5.9. Logs Export
- 5.10. Viewing and Printing Saved Data in PDF Format
- 6. Service and Maintenance
- 6.1. Introduction
- 6.2. Servicing the BIS™ Advance Monitor
- 6.3. Battery Handling
- 6.4. Cleaning the BIS™ Advance Monitor
- 6.5. Instrument Identification
- 7. Diagnostics and Troubleshooting
- 7.1. Diagnostics
- 7.2. Troubleshooting
- 7.3. Administrator Mode
- 7.4. Demo Mode
- 7.5. Glossary
- 7.6. Specifications
- 7.6.1. General Specifications
- 7.6.2. Operating Environments
- 7.6.3. Power Supply
- 7.6.4. Battery Specifications
- 7.6.5. Controls and Connectors
- 7.6.6. Alarms
- 7.6.7. Display
- 7.6.8. Sound Pressure Data
- 7.6.9. BIS Specifications
- 7.6.10. EEG Specifications
- 7.6.11. BISx Module Specifications
- 7.6.12. Software/GUI Specifications
- 7.7. Electromagnetic Compatibility Specifications
- 7.8. Product Compliance
- 7.9. BIS™ Advance Components, Accessories, and Documentation
- 7.10. Warranty
- 7.11. Software License Agreement
Product Compliance
250
BIS™ Advance Monitor
PSE Marking for power supply
FCC ID, FCC CFR 47 Part 15
Directive 2006/66/EC
UL 2054, 2nd edition (batteries)
IEC 62133-2 2017-02. (batteries)
UN 38.3
EU 2017/999 (REACH)
IEC 60601-1:1988 +A1/A2 & EN 60601-1:1990 +A11/A12/A13 Medical Electrical
Equipment Part 1: General Requirements for Safety (China)
IEC 60601-1:2005 + A1:2012 (medical devices in general) 2012.08 Medical
electrical equipment – Part 1: General requirements for basic safety and essential
performance
EN 60601-1:2006 + A12:2014
CAN/CSA-C22.2 No. 60601-1:14 Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-
1:2005, 2005-12), includes Corrigendum 1:2011.
EN/IEC 60601-1-2: 2014 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral Standard:
Electromagnetic disturbances – Requirements and tests, and the following
requirements defined in the EEG particular standard:
1. For Electrostatic Discharge (ESD) tests, ME Equipment may show temporary
degradation during discharges. Within 30 [seconds] the system shall resume
normal operation in the previous operating mode, without loss of any operator
settings or saved case data, and shall continue to perform its intended function.
2. For Radiated electromagnetic fields immunity - the test level shall be 3 V/m.
3. During Electrical Fast Transients (EFT) test, the system shall continue to display
the EEG waveform.